BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SP NOVUS

    MDR report key: 3862497 · Received June 10, 2014

    Report

    Report Number
    2649622-2014-06900
    Event Type
    Injury
    Date Received
    June 10, 2014
    Report Date
    March 14, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P830061
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT MEDICAL PRODUCTS: D314DRM IMPLANTABLE CARDIOVERTER DEFIBRILLATOR, IMPLANTED: (B)(6) 2012. A 5867-3M ADAPTOR, IMPLANTED: (B)(6) 2012. A 5076-52 IMPLANTABLE PACING LEAD, IMPLANTED: (B)(6) 2012. A 419488 IMPLANTABLE PACING LEAD, IMPLANTED: (B)(6) 2012. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD THRESHOLD LEVELS HAD BEEN INCREASING. INSULATION DAMAGE WAS OBSERVED PROXIMAL TO THE TYING SLEEVE DURING THE PROCEDURE WHEREIN THE LEAD WAS CAPPED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340473 CAPSURE SP NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 4592-45

    Patients

    Seq Age Sex Outcome Treatment
    1 00070 YR Hospitalization| R 6935M62 IMPLANTABLE TACHY LEAD